Biotech Values

[DewDiligence]

>MRX – I assume this law can be applied retroactively since Mylan has filed a Paragraph IV challenging the Solodyn patent.<

That sounds right—a P-IV challenge wouldn’t make much sense if the patent in question were not covered by the new law.

>But who (if at all) gets exclusivity?<

If MRX ends up settling with all challengers, there will not be any H-W 180-day exclusivity. Instead, MRX will license Solodyn to the settling challengers on terms that mimic the economic rewards of 180-day exclusivity.

If MYL forgoes a settlement and prevails against MRX in court, MYL (rather than Impax) gets the 180-day exclusivity. (Under the pre-2003 H-W rules, Impax would’ve retained the exclusivity despite settling.)